CONCEPT- PROPOSAL

 

1.   Title of the proposed research project:

Role of preoperative chlorhexidine mouth wash in the prevention of postoperative respiratory complications in patients with poor oral hygiene undergoing elective surgery - randomized controlled trial

 

2.  Rationale:

Postoperative respiratory complications account for a substantial proportion of morbidity and mortality related to surgery and anesthesia. Several studies aimed at identifying risk factors and and predictors have been conducted across the world. Various studies have shown patients with poor oral hygiene such as active caries and high plaque deposition are at higher risk of developing postoperative pulmonary complications. Gram negative, anaerobic, periodontal pathogens form biofilms on dental plaques and multiply within them subsequently resulting in periodontal disease, when left untreated. This is especially significant in the Indian scenario where a vast majority of patients belong to the lower socioeconomic status and lack of oral care is more prevalent in this strata. In addition, studies have also focused on the prevention and treatment of postoperative pulmonary complications and have found that active preoperative oral care with chlorhexidine mouth wash plays an important role in preventing and reducing the development of postoperative pulmonary complications by disinfecting the oral cavity. It has also shown to reduce incidence of surgical site infections and the length of hospital stay However, most of these studies have been limited to patients undergoing major thoracic, cardiac and bowel related surgeries and elderly patients with multiple co- morbidities. The role of preoperative oral hygiene in preventing or reducing postoperative pulmonary complications in patients undergoing other surgeries, particular short duration surgeries, is yet to be studied. Also, the existing studies have focused on pneumonia as the major complication. While pneumonia and respiratory failure are the major contributors to morbidity and mortality, others such as unexplained fever, excessive bronchial secretions, productive cough, abnormal breath sounds, atelectasis or hypoxaemia are often overlooked but can significantly prolong duration of hospital stay and increase medical cost which can be avoided. This study thus aims to identify the role of preoperative oral care in the form of chlorhexidine mouth wash in the prevention of postoperative respiratory complications in patients with poor oral hygiene undergoing elective surgery under general anesthesia.

 

 

 

 

3.   Novelty/Innovation:

 

Existing studies have particularly targeted thoracic, cardiac, bowel surgeries, neurosurgeries and elderly patients with multiple comorbidities with focus on the incidence of postoperative pneumonia in particular. These surgeries frequently require postoperative mechanical ventilation with higher probability of developing postoperative pneumonia, irrespective of oral hygiene status and make up only a small fraction of the spectrum of surgeries performed. In our study, we seek to see the role of oral hygiene independently, by removing the bias of surgeries with a higher risk of pulmonary complications, based on incidence of pneumonia as well as other complications such as, unexplained fever, excessive bronchial secretions, productive cough, all of which significantly contribute to perioperative morbidity.

 

4.   Project Description:

The proposed study is a prospective randomized double blind controlled trial. It will be conducted by department of anesthesiology, King George’s Medical University, Lucknow after getting ethical approval, in collaboration with the department of microbiology, general surgery and department of dental sciences, King George’s Medical University, Lucknow. The research will be conducted over a total period of three years of which 30 months will be dedicated to the study and six months each will be reserved for data collection and biostatistics.

 

Sample size :

The sample size was calculated based on a previous study that reported that the prevalence of dental problems was 75% in India (Varghese et al,, 2019), 95% level of confidence and Error rate, usually set at 0.05 level is 4. Total 288 patients will be included in this study.

n=Z2 P(1-P)/d2

Where,

●               n = sample size,

●              Z = Z statistic for a level of confidence, for the level of confidence of 95%, which is conventional, Z value is 1.96.

●                P = expected prevalence or proportion (in proportion of one; if 75%, P = 0.75),

●               d = precision (in proportion of one; if 5%, d = 0.05).

 

n=1.96x1.96x0.75x0.25/0.052

n=288.12

 

 

Varghese CM, Jesija J S, Prasad JH, Pricilla RA. Prevalence of oral diseases and risks to oral health in an urban community aged above 14 years. Indian J Dent Res 2019;30:844-50

 

Expected outcome: Based on the trend seen in preceding studies, we expect to find a positive co-relation between the use of preoperative chlorhexidine mouthwash in preventing postoperative pulmonary complications particularly in patients undergoing general anesthesia.

 

 

Feasibility:

 

 

5.  Strength of PI

 Dr Shefali Gautam, presently working as additional professor ,KGMU in department of Anaesthesiology and Critical Care. I have total ten years experience of research activities. She has published 36 publications in various peer reviewed journals. Since the year 2015 ,she is working as faculty at KGMU. She has supervised 6 thesis as guide ,co-supervised 14 MD/MS thesis and supervised 40 PG dissertations. In this project she will be responsible for all experimental work and she will coordinate between the department of general surgery and microbiology who are also part of this project. To keep herself updated with new research findings ,she regularly attends  and conducts conferences, seminar and workshops.

 

 

6.  Institutional Support:

Our institute has well developed microbiology department for all routine blood investigations and culture and pre and post op facilities.

 

FORMAT OF RESEARCH PLAN

 

1.         Title of the proposed research project:

Role of preoperative chlorhexidine mouth wash in the prevention of postoperative respiratory complications in patients with poor oral hygiene undergoing elective surgery under general anaesthesia - randomized controlled trial

 

2.  Summary:

 

Background: Postoperative pulmonary complications (POPC) considerably contribute to perioperative morbidity and mortality. We have hypothesized that preoperative oral care in patients with poor oral hygiene can prevent the development of postoperative respiratory complications like pneumonia.

Novelty: All related studies have been limited to major surgeries that have a higher predisposition for postoperative pneumonia. Till date, no other study has focused on multiple types of surgeries and postoperative respiratory complications other than pneumonia.

Objective: The primary objective is to see the incidence of postoperative complications, namely sore throat, fever, pneumonia, upper respiratory tract infections, lower respiratory tract infections, abnormal breath sounds in both the groups. The secondary objectives are to see its role on surgical site infections and duration of hospital stay.

Methods: Patients between 18-65 years of age with Oral Hygiene Index(OHI) more than 6, undergoing elective open abdominal surgery of less than 4 hours  duration divided into 2 groups randomly. Patients with active URTI/LRTI, COPD/asthma, active smokers, with alcohol abuse, diabetes mellitus, morbid obesity, any immune deficiency, heart insufficiency, those with known allergy to chlorhexidine, those on broad spectrum antibiotics and negative consent to participate in trial will also be excluded from the study.  All the patients will be given preoperative antibiotic prophylaxis with inj. cefuroxime 750 mg iv along with the two postoperative doses. Group A will receive 10 ml of chlorhexidine mouthwash 0.2% (w/v) while group B will receive 10ml of saline mouthwash for oral rinse for 10 minutes. Tracheal aspirate [broncho alveolar lavage] for culture will be collected just prior to extubation in all patients and on post operative day 3, and 7 if any patient develops signs of infection. CBC, Chest X Ray and CRP will be sent on day 3 and 7 days respectively and accordingly. Core body temperature, incidence of sore throat, excessive bronchial secretions, productive cough, abnormal broth sounds and need for supplemental oxygen will be monitored  till postoperative day 7.

3.  Keywords:

Oral hygiene, chlorhexidine, respiratory complications, general anaesthesia

 

4.  Abbreviations:

 

POPC- postoperative pulmonary complications OHI- Oral hygiene Index

URTI- upper respiratory tract infection LRTI- lower respiratory tract infection

COPD- Chronic Obstructive Pulmonary disease GA- general anaesthesia

DI-Debris Index CI- Calculus Index

VAP- ventilator associated pneumonia

 

 

5.  Background:

 

Postoperative respiratory complications account for a substantial proportion of morbidity and mortality related to surgery and anaesthesia. Several studies aimed at identifying risk factors and and predictors have been conducted across the world. Various studies have shown patients with poor oral hygiene such as active caries and high plaque deposition are at higher risk of developing postoperative pulmonary complications. Gram negative, anaerobic, periodontal pathogens form biofilms on dental plaques and multiply within them subsequently resulting in periodontal disease, when left untreated. Translocation of these pathogenic bacteria leads to respiratory infections. This is especially significant in the Indian scenario where a vast majority of patients belong to the lower socioeconomic status and lack of oral care is more prevalent in this strata. In addition, studies have also focused on the prevention and treatment of postoperative pulmonary complications and have found that active preoperative oral care with chlorhexidine mouth wash plays an important role in preventing and reducing the development of postoperative pulmonary complications by disinfecting the oral cavity. It has also shown to reduce incidence of surgical site infections and the length of hospital stay However, most of these studies have been limited to patients undergoing major thoracic, cardiac and bowel related surgeries and elderly patients with multiple co-morbidities. The role of preoperative oral hygiene in preventing or reducing postoperative pulmonary complications in patients undergoing other surgeries, particular short duration surgeries, is yet to be studied. Also, the existing studies have focused on pneumonia as the major complication. While pneumonia and respiratory failure

are the major contributors to morbidity and mortality, others such as unexplained fever, excessive bronchial secretions, productive cough, abnormal breath sounds, atelectasis or hypoxaemia are often overlooked but can significantly prolong duration of hospital stay and add to the burden of medical cost which can be avoided. This study thus aims to identify the role of preoperative oral care in the form of chlorhexidine mouth wash in the prevention of postoperative respiratory complications in patients with poor oral hygiene undergoing elective surgery under general anaesthesia(GA).

 

6.  Literature Review:

 

Ploenes T et al(2022)[1] carried out a prospective observational study on 230 adult adult patients undergoing elective thoracic surgery to see the co-relation of oral health status on perioperative outcomes. They found that patients with frequent dental visits and treated teeth had a lower risk for postoperative complications compared with patients without regular visits and patients with a high burden of caries had a significantly increased risk for pneumonia. They thus concluded that pathological oral health status is a modifiable factor predicting postoperative complications and pneumonia.

 

Itohara C et al(2020)[2] conducted a retrospective observational study on 441 consecutive patients who underwent surgery for lung cancer to evaluate the trends in the number of oral bacteria in the perioperative period and to verify the relationship between oral health status and postoperative fever using an oral bacteria counter. All patients received perioperative oral management (POM) by oral specialists. Statistical analysis revealed significantly higher oral bacteria counts at pre-hospitalization compared to pre- and post-operation (p < 0.001). They also found that POM can reduce the level of oral bacterial counts, that the risk of postoperative complications is lower with dentulous patients, and that appropriate POM is essential for prevent of complications. Therefore, they stated that POM may play an important role in perioperative management of lung cancer patients.

 

Ogawa PT et el(2020)[3] conducted a retrospective cohort study on 884 consecutive patients who underwent elective cardiovascular surgery to assess the impact of oral heath status on postoperative complications. They assessed the oral health status based on the number of remaining teeth, use of dentures, occlusal support, and periodontal status and investigated postoperative complications. On analyzing the collected data they found that prevalence of postoperative pneumonia and reintubation after surgery was significantly higher in patients with severe tooth loss (P < 0.05 for both).

Bardia A et al(2019)[4] conducted a systemic review and meta-analysis of 5 studies that assessed the effects of preoperative chlorhexidine gluconate mouthwash on postoperative pneumonia. Out of the 2284 patients that were included, a total of 1125 patients received preoperative chlorhexidine. All the studies revealed that use of chlorhexidine gluconate was associated with reduced risk of postoperative pneumonia compared with the patients who did not receive it (risk ratio, 0.52; 95% confidence interval, 0.39-0.70; P<.001). No adverse effects from chlorhexidine gluconate mouthwash were reported by any of these studies.

 

 

Soutane DDS et al(2017)[5] included 539 patients with esophageal cancer undergoing surgery in a multicenter case control study to investigate the effectiveness of oral care in prevention of postoperative pneumonia. Patients received oral health instruction, removal of dental calculus (scaling), professional mechanical tooth cleaning (PMTC), removal of tongue coating with a toothbrush, cleaning denture, and extraction of teeth with severe periodontitis showing pain, pus discharge, mobility, or marked alveolar bone loss by X-ray examination. Patients were instructed to clean teeth by toothbrush, interdental brush, dental floss, followed by gargling 3 timesaver day. At the end of their study, they found that longer operation time, postoperative dysphagia, and lack of oral care intervention to be)significantly correlated with postoperative pneumonia.

 

Abbas K, Ahmad SK(2016)[6] carried out a randomised control trial to evaluate the use of the preoperative chlorhexidine antiseptic mouthwash on the incidence of postoperative pneumonia on 385 patients undergoing thoracic surgery. Patients were randomly divided into two groups, one group(A) was given chlorhexidine mouthwash 10ml of 0.2% (w/v) preoperatively and the other (B) wasn’t. They observed that the incidence of the postoperative pneumonia was significantly reduced in the patients treated with preoperative chlorhexidine mouthwash (group A 10.52% v group B 2.56% p=0.003). The length of hospital stay was also found to be significantly shorter in the chlorhexidine group. VAP development rate was significantly higher in the control group than in the CHX group (68.8% vs. 41.4%, respectively; p = 0.03) with an odds ratio of 3.12 (95% confidence interval = 1.09-8.91). Thus they came to the conclusion that oral care with CHX swabbing reduces the risk of VAP development in mechanically ventilated patients.

 

Lin Y et al(2015)[7] performed a prospective randomized controlled trial to investigate the effect of preoperative 0.2% chlorhexidine on postoperative

ventilator associated pneumonia (VAP). Ninety-four patients scheduled for heart surgery were randomized to a chlorhexidine group (N = 47) or control (saline) group (N = 47). On the day before surgery, patients gargled three times with 0.2% chlorhexidine or saline 30 min after each meal and 5 min after teeth brushing at bedtime. VAP occurred in 8.5% of the chlorhexidine group and in 23.4% of the controls. Preoperative chlorhexidine mouthwash reduced the incidence of postoperative VAP significantly.

 

Nicolosi L et al(2014)[8] carried out a quasi-experimental study on 300 patients undergoing heart surgery to determine the effect of toothbrushing plus 0.12% chlorhexidine gluconate oral rinse in preventing VAP after CVS.

Patients in group 1 were enrolled in a protocol for controlling dental biofilm by proper oral hygiene (toothbrushing) and oral rinses with 0.12% chlorhexidine gluconate and they were compared with a historical control group (Group 2), which included patients who underwent cardiac surgery between 2009 and 2010 and who received regular oral hygiene care. Seventy-two hours before surgery, a dentist provided instruction and supervised oral hygiene with toothbrushing and chlorhexidine oral rinses to patients in Group 1. Statistics analysis   showed a lower incidence of VAP and a shorter hospital stay in Group 1The risk for developing pneumonia after surgery was 3-fold higher in Group 2 hence they came up with the cponclusion that oral hygiene and mouth rinses with chlorhexidine under supervision of a dentist proved effective in reducing the incidence of VAP.

Ozcaka O et al(2012)[9] conducted a randomised, double-blind, controlled

study on sixty-one dentate patients scheduled for invasive mechanical ventilation for at least 48 hours. As these patients were variably incapacitated, oral care was provided by swabbing the oral mucosa four times/dat with chlorhexidine in the CHX group (29 patients) and with saline in the control group (32 patients). Clinical periodontal measurements were recorded, and lower-respiratory-tract specimens were obtained for microbiological analysis on admission and when VAP was suspected. Pathogens were identified by quantifying colonies using standard culture techniques.

 

Bagyi et al(2009)[10] conducted a study on a matched cohort of 18 patients without postoperative lung complications comparing them to 5 patients who developed pneumonia within 48 hours after elective brain surgery. Patients underwent preoperative dental examination and saliva collection before surgery and were given 15 mg/kg cefazolin intravenously at the beginning of surgery. Serum, saliva and bronchial secretion were collected promptly after the operation. They observed that the number and severity of coexisting periodontal diseases were significantly greater in patients with postoperative pneumonia in comparison to the control group and the relative risk of developing

postoperative pneumonia in high periodontal score patients was 3.5 greater than in patients who had low periodontal score (p < 0.0001). Thus they concluded that presence of multiple periodontal diseases and pathogenic bacteria in the saliva are important predisposing factors of postoperative aspiration pneumonia in patients after brain surgery and dental examination may be warranted in order to identify patients at high risk of developing postoperative respiratory infections.

 

Houston S et al(2002)[11] performed a prospective, randomized, case-controlled clinical trial to test the effectiveness of 0.12% chlorhexidine gluconate oral rinse in decreasing microbial colonization of the respiratory tract and nosocomial pneumonia in patients undergoing open heart surgery. A total of 561 patients undergoing aortocoronary bypass or valve surgery requiring cardiopulmonary bypass were randomized to an experimental (n = 270) group that received 0.12% chlorhexidine gluconate or a control (n = 291) group that received Listerine (phenolic mixture). Nosocomial pneumonia was diagnosed by using the criteria established by the Centers for Disease Control and Prevention. overall rate of nosocomial pneumonia was reduced by 52% (4/270 vs 9/291; P = .21) in the Peridex-treated patients. Among patients intubated for more than 24 hours who had cultures that showed microbial growth (all pneumonias occurred in this group), the pneumonia rate was reduced by 58% (4/19 vs 9/18; P = .06) in patients treated with Peridex. In patients at highest risk for pneumonia (intubated > 24 hours, with cultures showing the most growth), the rate was 71% lower in the Peridex group than in the Listerine group (2/10 vs 7/10; P = .02).

 

DeRiso A et al(1996)[12] did a prospective, randomized, double-blind, placebo- controlled clinical trial to test the effectiveness of oropharyngeal decontamination on nosocomial infections in a comparatively homogeneous population of patients undergoing heart surgery. Three hundred fifty-three consecutive patients undergoing coronary artery bypass grafting, valve, or other open heart surgical procedures were randomized to an experimental (n=173) or control (n=180) group. The experimental drug chosen was 0.12% chlorhexidine gluconate (CHX) oral rinse. They found that the overall nosocomial infection rate was decreased in the CHX-treated patients by 65%, the incidence of total respiratory tract infections in the CHX-treated group was reduced by 69%. Gram-negative organisms were involved in significantly less (p<0.05) of the nosocomial infections and total respiratory tract infections by 59% and 67%, respectively. They also noted a reduction in mortality in the CHX-treated group. Thus they concluded that oropharyngeal decontamination with Chlorhexidine oral rinse reduces the total nosocomial respiratory infection rate and the use of nonprophylactic systemic antibiotics in patients undergoing heart surgery.

 

 

 

7.  Novelty:

 

Existing studies have particularly targeted thoracic, cardiac, bowel surgeries, neurosurgeries and elderly patients with multiple comorbidities with focus on the incidence of postoperative pneumonia in particular. These surgeries frequently require postoperative mechanical ventilation with higher probability of developing postoperative pneumonia, irrespective of oral hygiene status and make up only a small fraction of the spectrum of surgeries performed. In our study, we seek to see the role of oral hygiene independently, by removing the bias of surgeries with a higher risk of pulmonary complications, based on incidence of pneumonia as well as other complications such as, unexplained fever, excessive bronchial secretions, productive cough, all of which significantly contribute to perioperative morbidity.

 

8.  Study Objectives:

The primary objective of the study is to see the incidence of postoperative complications, namely sore throat, pneumonia, fever, URTI, LRTI, abnormal breath sounds in both groups.

The secondary objectives are to see its role on surgical site infections and duration of hospital stay.

 

9.  Methodology:

i.         Study Design: A randomized controlled trial

 

ii.  Sample Size:

The sample size was calculated based on a previous study that reported that the prevalence of dental problems was 75% in India (Varghese et al,, 2019), 95% level of confidence and Error rate, usually set at 0.05 level is

4.  Total 288 patients will be included in this study.

n=Z2 P(1-P)/d2

Where,

●          n = sample size,

●          Z = Z statistic for a level of confidence, for the level of confidence of 95%, which is conventional, Z value is 1.96.

●              P = expected prevalence or proportion   (in proportion of one; if 75%, P = 0.75),

●          d = precision (in proportion of one; if 5%, d = 0.05).

 

n=1.96x1.96x0.75x0.25/0.052

n=288.12

 

Varghese CM, Jesija J S, Prasad JH, Pricilla RA. Prevalence of oral diseases and risks to oral health in an urban community aged above 14 years. Indian J Dent Res 2019;30:844-50

iii.  Project implementation plan:

The proposed study is a prospective randomized controlled double blinded study aimed to identify role of chlorhexidine mouthwash in preventing postoperative respiratory complications in patients undergoing elective surgeries under general anaesthesia.

Patients of ASA grade I/II, with poor oral hygiene (OHI more than 6), between 18-65 years of age posted for elective abdominal surgeries of less than 4 hours duration under general anaesthesia using endotracheal tube were included in the study. Patients undergoing laparoscopic surgeries, thoracic, cardiac and major bowel surgeries and patients in which supraglottic devices were used for GA were excluded from the study. Patients with active URTI/LRTI, COPD/asthma, active smokers, with alcohol abuse, diabetes mellitus, morbid obesity, any immune deficiency, heart insufficiency, those with known allergy to chlorhexidine, those on broad spectrum antibiotics and negative consent to participate in trial will also be excluded from the study. Patients who have not smoked for a year or longer will be classified as not having a smoking habit. Patients in whom prompt postoperative extubation could not be anticipated or neurological complications appeared, or those requiring re-intubation or re-exploration and those surgeries that extend beyond 4 hours will be dropped from the study.

A routine standard preoperative check up will be done. Oral examination will be done by an experienced dentist. Eligibility and oral hygiene status will be graded by the Oral Hygiene Index (OHI). OHI is a dental index to assess the level oral hygiene a patient and has two components, Debris Index(DI) and Calculus Index(CI). These indices intern is based numerical determinant representing the amount of debris and calculus found on the buccal and lingual surfaces of each of the three segments of both the dental arches. The maxillary and mandibular arches are divided into 3 segments each. Segments 1 and 3 are distal to the left and right premolars respectively while segment 2 extends

between the canines. Each segment is represented by one tooth that has the most surface area covered by debris or calculus. Only fully erupted permanent teeth are scored and third molar and partially erupted teeth are not included. Debris is defined as soft foreign material loosely attached to a tooth surface. Calculus is a hard deposit formed by the mineralization of dental plaque. A plaque is defined as a yellowish grey substance that adheres tenaciously to an intraoral hard surface. Each segment is scored from 0-3. Debris is scored as 0= no debris or stain present, 1= soft debris covering less than 1/3rd of the tooth surface or presence of intrinsic stains without other debris present irrespective of surface area covered, 2 = soft debris covering more than 1/3rd but not more than 2/3rd of exposed tooth surface, 3 = soft debris covering more than 2/3rd of exposed tooth surface.

 

DI = debris score / number of segments scored

 

Calculus is scored as 0= no calculus present, 1= supragingival calculus covering not more than 1/3rd of the exposed tooth surface, 2= supragingival calculus covering more than 1/3rd but not more than 2/3rd of the exposed tooth surface or presence of individual flecks of sub gingival calculus around the cervical portion of the tooth or both, 3= supragingival calculus covering more than 2/3rd of the exposed tooth surface or a continuous heavy band of the subgingival calculus around the cervical portion of the tooth or both.

CI = calculus score / number of segments scored OHI= CI+DI

OHI ranges from 0-12 and the higher the score, poorer is the oral hygiene of the

patient. Patients with OHI of 6 or more will be included in the study.

All patients who give informed consent after screening eligibility for participation in the study will be examined by an experienced dentist one day prior to surgery to assess and document active caries, the number of affected teeth and whether periodontal disease is present in the oral cavity. Active periodontal disease, lost teeth and clinical signs of acute infection will also record. All the patients will be given preoperative antibiotic prophylaxis with inj. cefuroxime 750 mg iv along with the two postoperative doses. They will then be randomly divided into two groups by random computer-generated numbers in sealed envelopes. Group A will receive 10 ml of chlorhexidine mouthwash 0.2% (w/v) for oral rinse to be done for 10 minutes while group B will receive 10ml of saline mouthwash for oral rinse for 10 minutes. Both the patient and the observer will be blinded. A base line CBC will be collected in both the groups. The patients will be then administered general anaesthesia using standard anesthetic drugs followed by endotracheal intubation. After completion of surgery, extubation will be planned. Tracheal aspirate/broncho alveolar lavage for culture will be collected just prior to extubation along with post operative day  3, and 7 in whom culture will be positive or any signs of infection present. CBC, Chest X Ray and CRP will be sent on day 3

and day 7 for same. Core body temperature, incidence of sore throat, excessive bronchial secretions, productive cough, abnormal broth sounds and need for supplemental oxygen will be monitored till postoperative day 7. The diagnosis of postoperative pneumonia or LRTI will be made based on the guidelines for the management of hospital acquired pneumonia, which include:

•      Purulent tracheal secretions and new and/or persistent infiltrate on CXR, which is otherwise unexplained.

•     Increased oxygen requirement

•     Core temperature >38.3 o C

•     Blood leucocytes (>10,000/mm3) or leucopoenia (<4000/mm3).6

The diagnosis of postoperative pneumonia required the presence of all the criteria in the patients. URTI will be defined as patients who have all the criteria for pneumonia, but do not have a new or progressing infiltrate on chest radiograph.

Length of hospital stay and incidence of surgical site infection will be noted.

Surgical site infection (SSI) will be defined as a wound defect in which infection is present beneath the subcutaneous layers

 

iv.  Ethics Review:

Applied to institutional review board,KGMU,Lucknow for ethical clearance

 

v.  Data collection & statistical analysis plan:

The data obtained, will be analysed using Statistical Package for Social Sciences, version 21.0 or above. Patients will be compared between cases and controls. Chi-square test/Fisher exact test will be used.

 

 

10.   Expected outcome:

Based on the trend seen in preceding studies, we expect to find a positive co- relation between the use of preoperative chlorhexidine mouthwash in preventing postoperative pulmonary complications. It has been observed that rinsing the mouth with an antiseptic solution prevents growth of pathogenic bacteria. Thus, we hope to observe that preoperative mouthwash with chlorhexidine in patients with poor oral hygiene significantly prevents and/or reduces the incidence of pneumonia and other associated respiratory complications particularly in those patients who will be undergone general anesthesia via endotracheal intubation.

 

11.Limitations of study:

11. Limitations of study

•   Study is single -centre with small sample size. Large sample size is required to evaluate the influence of disease species and surgical procedures on postoperative respiratory complications in each group

•   Specific deviation in case selection

•   The effect of preoperative periodontal treatment on poor oral hygiene patients are not explored

•   The effect of some factors such as age, sex, diabetes and smoking are not analyzed

 

12.  Future plans based on expected outcome

The effect of preoperative periodontal treatment on poor oral hygiene patient as well as on high risk surgeries can be better studied and analysed with better postoperative outcomes

 

13. Time line

 

Total duration of project -2 years

1)Period needed for data collection-12 months 2)Period needed for follow up -6 months 3)Period needed for data analysis-6 months

 

14. Institutional support

Our institute has well developed general surgery department with large number of patients input for surgery, having well equipped modular operation theatre and post anesthesia care units. It has also microbiology department with advance laboratories and equipments.

 

15. Budget

 

Budget requirements (with detailed break-up and full justification):

 

 

	1st Year	2nd Year
Consumables	2,00,000/	200,000/
Contingencies	20,000/	20,000/
Travel	NA	NA
O v e r h e a d C h a rg e s	11,000/-	16000/-
Total	2,31,000/-	2,36,000/-

Grand Total: 4,67,000/-

 

 

 

 

 

REFERENCES

 

1.       Ploenes T, Pollok A, Jöckel K, Kampe S, Darwiche K, Taube C et al. The pathological oral cavity as a preventable source of postoperative pneumonia in thoracic surgery: a prospective observational study. Journal of Thoracic Disease. 2022;14(4):822-831.

2.       Itohara C, Matsuda Y, Sukegawa-Takahashi Y, Sukegawa S, Furuki Y, Kanno T. Relationship between Oral Health Status and Postoperative Fever among Patients with Lung Cancer Treated by Surgery: A Retrospective Cohort Study. Healthcare. 2020;8(4):405.

3.       Ogawa M, Satomi-Kobayashi S, Yoshida N, Tsuboi Y, Komaki K, Nanba N et al. Impact of Oral Health Status on Postoperative Complications and Functional Recovery After Cardiovascular Surgery. CJC Open. 2021;3(3):276-284.

4.       Bardia A, Blitz D, Dai F, Hersey D, Jinadasa S, Tickoo M et al. Preoperative chlorhexidine mouthwash to reduce pneumonia after cardiac surgery: A systematic review and meta-analysis. The Journal of Thoracic and Cardiovascular Surgery. 2019;158(4):1094-1100.

5.       Soutome S, Yanamoto S, Funahara M, Hasegawa T, Komori T, Yamada S et al. Effect of perioperative oral care on prevention of postoperative pneumonia associated with esophageal cancer surgery. 2022.

6.       Abbas K, Ahmad S. Outcomes following thoracic surgery: the role of preoperative chlorhexidine mouthwash in the prevention of post-operative pneumonia. International Surgery Journal. 2016;:921-926.

7.       Lin Y, Xu L, Huang X, Jiang F, Li S, Lin F et al. Reduced occurrence of ventilator-associated pneumonia after cardiac surgery using preoperative 0.2% chlorhexidine oral rinse: results from a single-centre single-blinded randomized trial. Journal of Hospital Infection. 2015;91(4):362-366.

8.       Nicolosi L, del Carmen Rubio M, Martinez C, Gonzalez N, Cruz M. Effect of Oral Hygiene and 0.12% Chlorhexidine Gluconate Oral Rinse in Preventing Ventilator-Associated Pneumonia After Cardiovascular Surgery. Respiratory Care. 2013;59(4):504-509.

9.          Özçaka Ö, BaÅŸoÄŸlu Ö, Buduneli N, TaÅŸbakan M, BacakoÄŸlu F, Kinane D. Chlorhexidine decreases the risk of ventilator-associated pneumonia in intensive care unit patients: a randomized clinical trial. Journal of Periodontal Research. 2012;47(5):584-592.

 

10.   Bágyi K, Haczku A, Márton I, Szabó J, Gáspár A, Andrási M et al. Role of pathogenic oral flora in postoperative pneumonia following brain surgery. BMC Infectious Diseases. 2009;9(1).

11.   Houston S, Hougland P, Anderson JJ, LaRocco M, Kennedy V, Gentry LO. Effectiveness of 0.12% chlorhexidine gluconate oral rinse in reducing prevalence of nosocomial pneumonia in patients undergoing heart surgery. Am J Crit Care. 2002 Nov;11(6):567-70.